Food Safety and Quality

The Food and Drug Administration (FDA) lacks a comprehensive strategy for monitoring animal drug residues in milk and cannot guarantee that illegal and possibly unsafe contaminants are not getting into milk or the rest of the food supply. A multitude of drugs are being used to treat dairy cows, but few are tested for in milk. States routinely test for only four drugs, while up to 82 drugs that leave residues in milk may be in use. FDA estimated in 1991 that as much as one percent of all milk had to be discarded because of excess residues from these four drugs. It is unclear how much other milk reached the market contaminated by drugs that are not tested for. More than half the drugs that are possibly being used on dairy cows are unapproved for such use, and some are not approved for any food-producing animal. The use of an animal drug on a dairy cow for reasons not specified on an FDA-approved label is known as "extra-label use." FDA expected that extra-label drug use by veterinarians would be rare and would be confined mainly to emergencies. GAO has discovered that such use is, in fact, routine. Extra-label use can lead to potentially unsafe residues in milk that escape detection, a prospect made even more unsettling by the fact that dairy farmers can buy most animal drugs over the counter. FDA has yet to identify additional drugs for testing or recommend more test methods for the states and industry to use. GAO summarized this report in testimony before Congress; see: Food Safety and Quality: FDA Strategy Needed to Address Animal Drug Residues in Milk, by John W. Harman, Director of Food and Agriculture Issues, before the Subcommittee on Human Resources and Intergovernmental Relations, House Committee on Government Operations. GAO/T-RCED-92-89, Aug. 5, 1992 (eight pages).

GAO found that: (1) FDA is responsible for approving new animal drugs, monitoring the distribution of drugs, and determining the safety of food products from treated animals; (2) by law, use of an animal drug in a manner inconsistent with its approved labelling is illegal; (3) under the FDA extra-label use policy, only veterinarians are allowed to use drugs in an unapproved manner, and only in emergencies; (4) states do most required monitoring, enforcement, and other regulation, while FDA ensures that states comply with all rules and regulations; (5) although reliable data are unavailable, approved and unapproved use of drugs on dairy cows is thought to be widespread; (6) states routinely test for only 4 of 82 drugs that could leave residues; and (7) states and the dairy industry were to expand their testing for drug residues, but FDA did not meet deadlines for recommending additional tests, and additional screening methods will not be available before 1993. GAO also found that: (1) limited enforcement of the extra-label use policy undermines FDA control of animal drugs; (2) veterinarians must rely on available information and their best judgment and experience in extra-label use cases, but may lack adequate information; (3) FDA cannot ensure that extra-label use conditions are followed by veterinarians because it does not routinely monitor compliance or have the ability to detect all residues; (4) drug manufacturers may have little incentive to obtain approval for new drugs and uses due to veterinarians' indiscriminate use and FDA inability to enforce its policies; and (5) proposed legislation to legalize extra-label use may provide a further disincentive to manufacturers.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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